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| Name | Class |
|---|---|
| Jiangsu Carefree Pharmaceutical Co., Ltd. | INDUSTRY |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
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Sodium tanshinone IIA sulfonate (STS) is a water-soluble derivative of tanshinone IIA isolated as the main pharmacologically active natural compound from a traditional Chinese herbal medicine,the dried root of Salvia miltiorrhiza Bunge known as Danshen. Danshen has been known for the function of improving body functions such as activating blood circulation and removing blood stasis according to the theory of traditional Chinese medicine. Danshen and its various formula products including STS have been long-time widely used in oriental countries, especially China to treat various inflammatory and cardiovascular diseases for its pharmacological actions, including vasodilatation, anticoagulation, anti-inflammation, and free radical scavenging,with negligible adverse effects observed.
The investigator's objective is to evaluate whether STS exhibits beneficial effects on pulmonary hypertension. This is a randomized, controlled, multicentre clinical trial study. 90 patients with pulmonary hypertension will be enrolled in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20 mg sildenafil citrate tablets by mouth | Active Comparator | 20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks |
|
| sodium tanshinone IIA sulfonate, sildenafil citrate tablets | Experimental | sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection also permitted if necessary) 250ml ivdrip once a day for 8 weeks,20mg sildenafil citrate tablets by mouth three times a day for the same duration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20 mg sildenafil citrate by mouth | Drug | 20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| mPAP by right heart catheterization | To assess if sodium Tanshinone IIA sulfonate decreases mean pulmonary arterial pressure. | At the end of 0- and 8-week trial |
| Measure | Description | Time Frame |
|---|---|---|
| WHO functional class of pulmonary hypertension(PH) | At the end of 0-,2-, 4-,6- and 8-week of trial | |
| Borg dyspnea score | At the end of 0-, 2-,4-,6- and 8-week trial | |
| Measure | Description | Time Frame |
|---|---|---|
| The level of N terminal-proBNP(NT-proBNP),cardiac troponin I(cTnI) and uric acid(UA) in serum | The three indicators are used to evaluate whether STS alleviates right heart failure. | At the end of 0-,4- and 8-week trial |
| Indicators monitoring STS safety |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Wang, MD | Contact | +8615013388183 | jwang31@jhmi.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37732786 | Derived | He X, Yang F, Wu Y, Lu J, Gao X, Zhu X, Yang J, Liu S, Xiao G, Pan X. Identification of tanshinone I as cap-dependent endonuclease inhibitor with broad-spectrum antiviral effect. J Virol. 2023 Oct 31;97(10):e0079623. doi: 10.1128/jvi.00796-23. Epub 2023 Sep 21. |
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| Sir Run Run Shaw Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Beijing Chao Yang Hospital | OTHER |
| Beijing Anzhen Hospital | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
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| sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth | Drug | sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection will also be permitted if necessary) 250ml iv drip once a day for 8 weeks,as well as 20mg sildenafil citrate tablets by mouth three times a day for the same duration of treatment |
|
|
| Minnesota living with heart failure questionnaire |
| At the end of 0-,2-, 4-,6- and 8-week trial |
| 6-minute walk distance (6MWD) | To assess if sodium Tanshinone IIA sulfonate improves the exercise capacity of patients with pulmonary hypertension. | At the end of 0-, 2-, 4-, 6- and 8-week trial |
| Pulmonary vascular resistance(PVR) measured by right heart catheterization | PVR is used to evaluate whether STS decreases mPAP or increases pulmonary circulatory blood flow. | At the end of 0- and 8-week trial |
The blood routine test,urine routine test,liver and kidney function and blood clotting function will be examined and some worsening events,such as death,PH aggravation,need to add other unscheduled target drugs,need to be hospitalized or prolonged hospitalization,lung and/or heart transplantation and/or any other severe adverse events surely or very likely due to STS,will be closely observed as the safety indications of STS.
| At the end of 0-,4- and 8-week trial |
| Other hemodynamic parameters measured by right heart catheterization | To evaluate whether STS has beneficial effects on hemodynamic parameters. | At the end of 0- and 8-week trial |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| D002318 | Cardiovascular Diseases |
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| C024894 | tanshinone II A sodium sulfonate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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